Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?

Early Phase 1

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Other: Placebo; Drug: Vitamin D2

• Registration Number: NCT04450199
• Lead Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Brief Summary

To assess if vitamin D status in the elective foot and ankle fusion population affects fusion healing categorically (fused vs. un-fused).

Detailed Description

This study will be a randomized, 1:1 placebo controlled, blinded, prospective study of level I evidence. The investigators will recruit patients undergoing a major ankle, hindfoot, or midfoot arthrodesis and obtain serum vitamin D levels. Patients that are vitamin D deficient (\<30 ng/mL) will then be randomized into two treatment groups: vitamin D supplementation (50,000 IU D2) and no vitamin D supplementation, receiving placebo. Vitamin D levels will be drawn on the day of surgery and 6-8 weeks post-operatively. Outcome variables tested in this study are as follows: bone fusion as an event, time to bone fusion, VAS, and SF-36.

The study will be conducted at 4 investigative sites within the Allegheny Health Network; West Penn Hospital, Forbes Regional Hospital, Twin Towers and Steel Valley Orthopedics \& Sports Medicine, Jefferson Hills, PA. Recruitment will stop when approximately 150 subjects are entering the follow-up phase of the study.

Study Timeline

• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-06-29
• Study Start: 2020-07-24
• Status Verified: 2023-08
• Primary Completion: 2023-12-01
• Study Completion: 2024-03-11
• Last Update Submitted: 2024-06-16
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Males or females age 18 to 89 years undergoing ankle, hindfoot, or midfoot arthrodesis surgery
2. Vitamin D serum level <30 ng/mL including those concurrently taking vitamin D
3. Ambulatory
4. Women 18 years of age must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.

Exclusion Criteria

1. Revision surgery

2. Tobacco use which has been shown to affect bone healing and increase risk of nonunion

3. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease (EXAMPLE below):

   AST/SGOT > 2.0 times the upper limit of normal ALT/SGPT > 2.0 times the upper limit of normal Total bilirubin > 2.0 times the upper limit of normal Hemoglobin < 9 gm/dL White blood cell count < 3,000/ mm3 Platelet count < 100,000/mm3 Creatinine > 2.0 times the upper limit of normal

4. Preexisting disorders known to adversely affect bone healing (e.g. diabetes mellitus with HbA1C greater than or equal to 7, peripheral vascular disease, certain connective tissue disorders, and congenital or acquired disorders of bone metabolism)

5. Preexisting disorders affecting Vitamin D metabolism and/or calcium phosphate homeostasis (e.g. renal failure, hepatic failure, congenital defects in vitamin D metabolism, parathyroid disorders, conditions causing abnormal calcium and/or phosphate absorption)

6. Open wounds to lower extremities which has been shown to increase risk of infection and nonunion

7. Any investigational drug use within 30 days prior to enrollment.

8. Participation in ongoing clinical research

9. Pregnant or lactating females.

10. Patients who are unable to swallow due to acuity of illness or physiologic reason

11. Patients who are unable to provide consent for the study including inability to read or speak English

12. Prisoners who are patients because of their vulnerable population and inability to follow-up

13. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	12 over encapsulated placebo tablets
Vitamin D	Vitamin D2	12 over encapsulated 50,000 IU Vitamin D2

Primary Outcome Measures

Name	Time	Method
Time to Union	9 months	Arthrodesis Union using radiographic union determined by independent reviewers

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes SF-36 Questionnaire	9 months	Change in patient reported SF-36 questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Patient Reported Outcomes VAS Survey Scores	9 months	Change in patient reported VAS survey scores. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". ... The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst."

Trial Locations

Locations (1)

The Foot & Ankle Institute/Western Pennsylvania Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States